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NCT Number: NCT06957717

Effect of Cow's Milk Kefir on Short Chain Fatty Acid (SCFA), Haemoglobin, and Ferritin Levels of Anemic Adolescent Girls

Introduction: The prevalence of anemia among adolescent girls in Indonesia is still quite high. According to the Indonesian Health Survey (IHS) in 2023, it was 18% and is still a national problem. Long-term supplementation of blood supplement tablets (TTD) as an effort made by the government to prevent/overcome anemia has caused side effects, namely dysbiosis by pathogenic bacteria. Giving cow's milk kefir containing various probiotics can overcome the side effects of supplementation, and its metabolites accelerate iron absorption so that iron status in the blood increases and ultimately restores anemia in adolescent girls. Method: It's research is an experimental study, with a Randomized Controlled Trial (RCT) design, pre-posttest design, involving research subjects of adolescent girls (15-18 years) with mild and moderate anemia, at SMKN 1, 2, and 3 Kasihan, Bantul Regency, Yogyakarta as many as 80 students. Subjects were divided into 2 groups, namely group 1 (treatment group), which was given 120 ml of cow's milk kefir every day and TTD 1 grain/week, and group 2 (control group), which was given 120 ml of cow's milk every day and TTD 1 grain/week. The duration of administration was 2 months. The study outcomes were Short Chain Fatty Acid (SCFA) levels in feces by Gas Chromatography-Mass Spectrometry (GC-MS) method, hemoglobin by Hematology Analyser method, and serum ferritin by Ferritin ELISA measured at the beginning and end of the study. Statistical analysis included univariate, bivariate, and multivariate analysis. Clinical analysis was also conducted to estimate the effect size of the treatment

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Key information

Age range

15 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gadjah Mada University

Yogyakarta, Special Region of Yogyakarta, 55281, Indonesia

Location contact

Bernadette Josephine Istiti Kandarina, Co-promotor

SUB_INVESTIGATOR

Lusyana Gloria Doloksaribu, Doctoral student

CONTACT

[email protected]

085360637111

Lusyana Gloria Doloksaribu, Doctoral student

PRINCIPAL_INVESTIGATOR

Susetyowati Susetyowati, Promotor

SUB_INVESTIGATOR

Susetyowati, Promotor

CONTACT

[email protected]

0818277781

About this study

This protocol represents the only doctoral research dissertation proposal I will undertake as part of my dissertation, which does not exist.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adolescent girls aged 15-18 years
  • Have a mild and moderate degree of anemia (Hb 8-11.9 g/dl)
  • Have a normal menstrual cycle and duration

Exclusion criteria

  • Suffering from thalassemia, hemosiderosis, blood cancer, and malaria, based on the doctor's diagnosis in the last 3 months
  • Taking supplements other than TTD
  • Taking antibiotics in the last 3 months
  • Suffering from lactose intolerance through interviews

Treatment and study plan

cow's milk kefir

Combination Product

group given cow's milk kefir and blood supplement tablets (TTD)

Other names: intervention group

pasteurized cow's milk

Combination Product

group given pasteurized cow's milk and blood supplement tablets (TTD)

Other names: control group

Primary outcomes

  1. Short Chain Fatty Acid

    Time frame: 2 months after intervention

    SCFA (acetate, propionate, and butyrate) levels in fresh feces of adolescent girls, using the GC-MS (Gas Chromatography-Mass Spectrometry) Method, were measured before (0 months) and after the intervention (2 months), using a ratio scale.

    The examination procedure included collecting feces in the field according to the procedure at https://drive.google.com/drive/folders/1uXklwFuC-1rnQ1Anim86b7-9pqLSheIz. Fresh feces samples were collected immediately, by storing them in a cool box (to maintain the quality of feces so that it remains stable during storage and transportation, and avoid the maturation process that can affect the results of lab tests, so that the results of the lab analysis carried out can be accurate and valid), and then immediately taken to the laboratory to quantify each of the short chain fatty acids (SCFA) in the sample.

  2. hemoglobin

    Time frame: 2 months after intervention

    Adolescent girls' hemoglobin values in the blood taken from the median cubital vein, using the hematology analyzer method (unit g/dl), were measured before (0 months) and after the intervention (2 months), using a ratio scale.

  3. Ferritin

    Time frame: 2 months after intervention

    Ferritin content in the blood of adolescent girls taken from the median cubital vein, using the Ferritin ELISA method (unit µg/L), was measured before (0 months) and after the intervention (2 months), using a ratio scale

Secondary outcomes

  1. Nutrient intake

    Time frame: 2 months after intervention

    The amount of nutrients iron, folic acid, protein, vitamin C, zinc, energy and fat that enter the body of adolescent girls per day obtained from food and beverages, using the Food Record method carried out for 3 days, consisting of 2 times weekday and 1 time weekend, analyzed using the Nutrisurvey 2007 application, measured before (0 months) and after the intervention (2 months), using a ratio scale.

  2. Nutritional status of adolescent girls (body mass index / age)

    Time frame: 2 months after intervention

    The Z-score or standard deviation (SD) value of adolescent girls after calculating the ratio of body weight in kilograms (kg) squared with height in meters (m) correlated with age, was analyzed using the WHO AnthroPlus application, measured before (0 months) and after the intervention (2 months), using a ratio scale.

    Weight values were obtained by weighing adolescent girls using digital scales with an accuracy of 0.1 kg. Height values were obtained by measuring the height of adolescent girls using a microtoise with an accuracy of 0.1 cm, and age was obtained by asking about the date/month/year of birth of adolescent girls. Using a questionnaire.

  3. Menstrual cycle and duration of adolescent girls

    Time frame: 2 months after intervention

    The physiological process experienced by adolescent girls, namely periodic bleeding from the uterus accompanied by the release of the endometrial wall every month, was obtained through a questionnaire, using an ordinal scale, with the categories (1). Normal if the menstrual cycle ranges from 21-35 days, and the length of menstruation is 3-7 days, and (2). Abnormal if the menstrual cycle ranges <21 days and >35 days, and the duration of menstruation is <3 days and >7 days

  4. Diarrhea

    Time frame: 2 months after intervention

    Complaints of watery or loose bowel movements that occur more than 3 times a day were obtained through a questionnaire, using an ordinal scale, with the categories (1). No diarrhea if the frequency of bowel movements ranged from 1-2 times/day, with a solid consistency, and (2). Diarrhea, the frequency of bowel movements ranging ≥3 times/day, watery, thin consistency

Study contacts

Contact information is provided by the study sponsor or research team.

Lusyana Gloria Doloksaribu

CONTACT

[email protected]

085360637111

Sponsors and collaborators

Lead sponsor

Lusyana Gloria Doloksaribu

Other

Registry information

Official study title

Effect of Cow's Milk Kefir on Short Chain Fatty Acid (SCFA), Haemoglobin, and Ferritin Levels of Anemic Adolescent Girls in Yogyakarta, Indonesia

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 4, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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